The present invention relates to micronutrient supplements. More particularly, the present invention relates to micronutrient supplements comprising iron which are especially useful for administration to infants.
Micronutrient malnutrition may be defined as the insufficient dietary consumption of nutrients such as vitamin A, iron and iodine. It is a significant problem affecting more than 2 billion people worldwide, particularly women and children living in poverty. Iron deficiency is the most common nutritional problem in the world, affecting two thirds of children in most developing nations. Anemia resulting from iron deficiency in young children has become very common since the level of bioavailable iron in a typical infant""s diet is low while their rapid growth requires a much higher level of iron. The consequences of iron deficiency anemia (IDA) are very serious as it is associated with impaired cognitive and psychomotor development, reduced growth and decreased resistance to infection.
The age group at most risk is infants 6 to 24 months of age. Infants up to 6 months of age are protected from deficiency by iron stores present at birth and iron obtained from breast milk. Children 2 years of age and older obtain bioavailable iron from a diversifying diet. For infants between the ages of 6 to 24 months, however, iron obtained from breast milk cannot sufficiently meet the needs of rapid growth, while the solid food diet of this age group is not diversified enough to provide the required iron.
Micronutrient malnutrition, and more particularly iron deficiency, can be prevented, or at least controlled, by diet diversification, food fortification and nutrient supplementation. However, these solutions cannot readily be implemented in developing countries. For example, the ability of those in developing countries to diversify their diet is dictated not only by the availability of foods with a high nutrient content, but more importantly by the cost of such foods. Iron-fortified foods are, of course, an appropriate, effective means to prevent anemia; however, the cost of these foods is prohibitive to most families living in developing countries. The solution appears to lie in the remaining alternative, iron supplements, assuming that suitable cost-effective supplements can be developed for administration to infants and young children.
Currently, iron supplements are available for administration to infants and young children in the form of a concentrated solution or syrup due to the fact that they cannot swallow tablets or pills. However, in comparison to the use of tablets or pills, use of these formulations is associated with significant disadvantages. At the outset, shipping and storage of such iron-containing formulations is more costly and these formulations have a shorter shelf-life than comparable tablets or pills. Solution formulations are also more complicated to dispense and, as a result, there exists a higher likelihood of dispensing incorrect dosages. Further, there is poor compliance with liquid formulations because of their unpleasant metallic taste. Finally, administration of iron in solution can cause stains on teeth, a disadvantage which is reversible but undesirable in the interim.
There is a need, thus, to provide a cost-effective iron supplement suitable for administration to infants and young children which is useful to prevent iron deficiency anemia.
The present invention provides a composition supplemented with iron which is particularly suitable for administration to infants, and more particularly, suitable for administration to infants and young children, i.e. children under 2 years of age.
Accordingly, in one aspect, the present invention provides a composition comprising micro-encapsulated iron granules in combination with a pharmaceutically acceptable lipid-based excipient.
In another aspect of the present invention, there is provided a method for preventing iron deficiency anemia in a mammal comprising the steps of adding a therapeutically effective amount of a composition comprising micro-encapsulated iron granules and a pharmaceutically acceptable lipid-based excipient to food and administering the food to said mammal.
In another aspect of the present invention, there is provided an article of manufacture comprising packaging material and a pharmaceutical composition contained within said packaging material, wherein said pharmaceutical composition is therapeutically effective to prevent iron deficiency anemia, and wherein the packaging material comprises a label which indicates that the composition comprises iron and that iron ingestion is effective to prevent iron deficiency anemia, said composition comprising a therapeutically effective amount of micro-encapsulated iron granules in combination with a pharmaceutically acceptable lipid-based excipient.
In yet another aspect of the present invention, there is provided an article of manufacture comprising packaging material and a pharmaceutical composition contained within said packaging material, wherein said pharmaceutical composition is therapeutically effective to prevent iron deficiency anemia, and wherein the packaging material comprises a label which indicates that the composition can bemused to prevent iron deficiency anemia, said composition comprising a therapeutically effective amount of micro-encapsulated iron granules in combination with a pharmaceutically acceptable lipid-based excipient.
The present composition advantageously provides iron in a form which is readily administrable on addition to food, requiring no further preparation prior to administration. When added to food, the composition does not adversely affect the taste or appearance of food because it is encapsulated, thereby preventing any leaching that might otherwise occur. Moreover, the provision of micro-encapsulated iron in a lipid-based excipient makes the present composition useful for administration to infants, particularly between the ages of 6-24 months, an age group which is especially vulnerable to iron deficiency. In this regard, the composition can be added directly to infant foods, including cereals, purees, formula and milk.